DJO Surgical
Stem, HIP, Alpha II, Modular Revision #6 RT Porous Coated Bowed 18.0
13manufacturers in China registered for this device type
51catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K973119 |
| Record published | 2018-08-27 |
| Record revised | 2020-04-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-02-044 | In distribution | |
| 434-28-208 | In distribution | |
| 400-02-054 | In distribution | |
| 435-28-206 | In distribution | |
| 433-32-209 | In distribution | |
| 435-28-207 | In distribution | |
| 400-02-052 | In distribution | |
| 652-06-180R | In distribution | |
| 435-28-211 | In distribution | |
| 402-32-000 | In distribution | |
| 400-02-060 | In distribution | |
| 434-28-212 | In distribution | |
| 402-28-000 | In distribution | |
| 400-02-046 | In distribution | |
| 435-28-208 | In distribution | |
| 433-32-211 | In distribution | |
| 652-03-135R | In distribution | |
| 433-32-208 | In distribution | |
| 402-28-010 | In distribution | |
| 400-02-048 | In distribution | |
| 652-02-120L | In distribution | |
| 432-22-203 | In distribution | |
| 435-28-212 | In distribution | |
| 400-02-056 | In distribution | |
| 402-28-005 | In distribution | |
| 435-28-210 | In distribution | |
| 652-07-195R | In distribution | |
| 434-28-209 | In distribution | |
| 402-32-005 | In distribution | |
| 402-28-500 | In distribution | |
| 402-32-010 | In distribution | |
| 434-28-206 | In distribution | |
| 434-28-207 | In distribution | |
| 432-22-202 | In distribution | |
| 400-02-042 | In distribution | |
| 434-28-211 | In distribution | |
| 400-02-050 | In distribution | |
| 433-32-212 | In distribution | |
| 435-28-205 | In distribution | |
| 400-02-040 | In distribution | |
| 432-22-201 | In distribution | |
| 433-32-210 | In distribution | |
| 652-06-180L | In distribution | |
| 434-28-205 | In distribution | |
| 652-07-195L | In distribution | |
| 402-32-500 | In distribution | |
| 435-28-209 | In distribution | |
| 400-02-058 | In distribution | |
| 434-28-210 | In distribution | |
| 652-05-165L | In distribution | |
| 433-32-207 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2008-05-08 | Not classified | Nonconforming Material/Component | Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12. | 20 units | 2009-09-08 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.